FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BBL™ Haemophilus Test Medium Agar (HTM Agar)
DI: 10382902219542
·
Model: 221954
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- BD BBL™ Haemophilus Test Medium Agar (HTM Agar)
- Primary DI
- 10382902219542
- Version / Model
- 221954
- Catalog Number
- 221954
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-12-21
- Public Version
- 4
- Public Version Date
- 2023-10-13
- Public Version Status
- Update
- Public Device Record Key
- 3696d5b1-0fbe-4932-a951-2d1d43c18578
- Distribution End Date
- 2022-04-15
Device Description
Plate Haemophilus Test Medium Agar 8 Ea
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSO | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR | Microbiology | 866.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58611 | Haemophilus species antimicrobial susceptibility culture medium IVD | A supplemented culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on Haemophilus species isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382902219546 | GS1 | Shelfpack | 2 | Not in Commercial Distribution | 2022-04-15 |
| Primary | 10382902219542 | GS1 | ||||
| Unit of Use | 00382902219545 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894216 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 15 | Millimeter | |
| Outer Diameter | 150 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius